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Cervical spondylotic radiculopathy (CSR) is one of the most common manifestations of cervical spondylosis and is characterized by neck pain radiating to the upper extremities, sensory disturbances, restricted cervical range of motion, and functional disability. Conservative treatment is recommended as the first-line management for most patients, and electroacupuncture is widely used in Traditional Medicine to relieve pain and improve function.
Cervical Huatuo Jiaji (EX-B2) acupuncture points are anatomically located adjacent to the cervical spinal nerve roots and may provide more targeted therapeutic effects than conventional meridian acupuncture points. Pulsed electromagnetic field (PEMF) therapy has also been used as an adjunctive physical modality to reduce pain and facilitate functional recovery.
This randomized controlled trial aims to evaluate whether high-frequency electroacupuncture at cervical Huatuo Jiaji (EX-B2) points combined with PEMF therapy provides greater improvement in pain intensity, cervical function, and safety outcomes than conventional high-frequency electroacupuncture combined with PEMF therapy in patients with cervical spondylotic radiculopathy caused by cervical spondylosis.
The primary outcome is pain intensity measured using the Visual Analog Scale (VAS). Secondary outcomes include cervical range of motion, Neck Disability Index (NDI), and treatment-related adverse events. Clinical outcomes will be assessed at baseline, after one week of treatment, and at the end of the two-week treatment period.
This study is designed as a prospective, randomized, single-blind, parallel-group controlled trial. A total of 104 patients diagnosed with cervical spondylotic radiculopathy caused by cervical spondylosis will be recruited and randomly assigned in a 1:1 ratio into two groups using a computer-generated randomization sequence. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes.
Experimental Group: Patients will receive high-frequency electroacupuncture (100 Hz) at bilateral cervical Huatuo Jiaji (EX-B2) points corresponding to the C4-C5, C5-C6, C6-C7, and C7-T1 spinal segments combined with pulsed electromagnetic field (PEMF) therapy.
Active Comparator Group: Patients will receive high-frequency electroacupuncture (100 Hz) at conventional meridian acupuncture points on the affected side combined with the same pulsed electromagnetic field (PEMF) therapy.
Treatment Procedure:
Data Collection and Evaluation:
Outcome measures will be assessed at three predefined time points:
The primary and secondary outcomes include:
Pain intensity: Measured using the Visual Analog Scale (VAS). Cervical range of motion: Measured using a cervical goniometer. Functional disability: Measured using the Neck Disability Index (NDI). Safety: Recording treatment-related adverse events, including bleeding, hematoma, localized pain, dizziness, needle syncope, allergic reactions, infection, and other intervention-related adverse events throughout the study period.
To ensure objectivity, outcome assessments will be conducted by blinded physicians who are not involved in participant recruitment, treatment administration, or randomization. During data entry and statistical analysis, treatment allocation will be coded as Group A and Group B to minimize assessment bias. Statistical analyses will be performed using Generalized Estimating Equations (GEE), with statistical significance defined as a two-sided P value <0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Frequency Electroacupuncture at Cervical Huatuo Jiaji (EX-B2) + PEMF | Experimental | Participants receive high-frequency electroacupuncture (100 Hz) at bilateral cervical Huatuo Jiaji (EX-B2) points corresponding to the C4-C5, C5-C6, C6-C7, and C7-T1 spinal segments combined with pulsed electromagnetic field (PEMF) therapy. Treatment is administered once daily, Monday through Friday, for two consecutive weeks (10 treatment sessions). |
|
| Conventional High-Frequency Electroacupuncture (Meridian Points) + PEMF | Active Comparator | Participants receive high-frequency electroacupuncture (100 Hz) at conventional meridian acupuncture points on the affected side combined with the same pulsed electromagnetic field (PEMF) therapy. Treatment is administered once daily, Monday through Friday, for two consecutive weeks (10 treatment sessions). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Frequency Electroacupuncture at Cervical Huatuo Jiaji (EX-B2) | Procedure | High-frequency electroacupuncture (100 Hz) is applied to bilateral cervical Huatuo Jiaji (EX-B2) acupuncture points at the C4-C5, C5-C6, C6-C7, and C7-T1 spinal segments using standardized stimulation parameters. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity measured by the Visual Analog Scale (VAS) | Pain intensity will be assessed using the 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain). The primary outcome is the change in VAS score over the treatment period and the comparison of changes between the two treatment groups. | Baseline (N0), Day 7 (N7), and Day 14 (N14) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cervical range of motion (ROM) | Cervical range of motion (flexion, extension, lateral flexion, and rotation) will be measured using a cervical goniometer. Changes from baseline will be compared between the two treatment groups. | Baseline (N0), Day 7 (N7), and Day 14 (N14) |
| Change in Neck Disability Index (NDI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Medicine and Pharmacy at Ho Chi Minh City | Recruiting | Ho Chi Minh City | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29796373 | Background | Suzuki A, Daubs MD, Hayashi T, Ruangchainikom M, Xiong C, Phan K, Scott TP, Wang JC. Patterns of Cervical Disc Degeneration: Analysis of Magnetic Resonance Imaging of Over 1000 Symptomatic Subjects. Global Spine J. 2018 May;8(3):254-259. doi: 10.1177/2192568217719436. Epub 2017 Aug 17. | |
| Background | Ha Hoang Kiem. Degenerative Joint Diseases: Diagnosis, Treatment and Prevention. Sports and Tourism Publishing House. 2018. | ||
| Background | Nguyen Thi Uyen Thi, Phan Quan Chi Hieu. Comparison of the analgesic effect between cervical Huatuo Jiaji electroacupuncture and conventional electroacupuncture in patients with cervical spondylotic radiculopathy caused by cervical spondylosis. Master's Thesis. University of Medicine and Pharmacy at Ho Chi Minh City. 2014. | ||
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Individual participant data (IPD) will not be shared outside the research team in order to protect participant confidentiality and privacy.
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Participants will be randomly assigned in a 1:1 ratio to either high-frequency electroacupuncture at cervical Huatuo Jiaji (EX-B2) points combined with pulsed electromagnetic field (PEMF) therapy or conventional high-frequency electroacupuncture combined with the same PEMF therapy. Participants will remain in their assigned treatment group throughout the study.
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This study is single-blind. Outcome assessors are independent physicians who are not involved in participant recruitment, treatment administration, or randomization and remain blinded to treatment allocation throughout the study. Treatment allocation is coded as Group A and Group B during data entry and statistical analysis to minimize assessment bias.
|
| Pulsed Electromagnetic Field Therapy | Device | Pulsed electromagnetic field (PEMF) therapy is administered according to the standardized treatment protocol during each treatment session. |
|
| Conventional High-Frequency Electroacupuncture | Procedure | High-frequency electroacupuncture (100 Hz) is applied to conventional meridian acupuncture points on the affected side according to the standardized treatment protocol. |
|
Functional disability related to neck pain will be assessed using the Neck Disability Index (NDI). Changes in NDI scores over time and between treatment groups will be evaluated. |
| Baseline (N0), Day 7 (N7), and Day 14 (N14) |
| Treatment-related adverse events | Treatment-related adverse events, including bleeding, hematoma, localized pain, dizziness, needle syncope, infection, allergic reactions, and other intervention-related adverse events, will be recorded throughout the study. | From the first treatment session until Day 14 |
| Background |
| Takagi I, Eliyas JK, Stadlan N. Cervical spondylosis: an update on pathophysiology, clinical manifestation, and management strategies. Dis Mon. 2011 Oct;57(10):583-91. doi: 10.1016/j.disamonth.2011.08.024. No abstract available. |
| Background | ICH Harmonised Guideline E6(R3). Guideline for Good Clinical Practice. International Council for Harmonisation. 2025. |
| Background | Li W, Qu Y, Chen S, Zou X, Xia C, Ding D. Research Progress on Acupuncture Treatment for Cervical Spondylotic Radiculopathy. Zhong Yi Xue. 2024;13(10):2672-2677. |
| Background | Guo JK, Cheng K, Zhu XC, Gong LD, Wu JT, Li JY. Clinical Observation on the Electro-acupuncture at Cervical Jiaji Point in the Treatment of Acute Cervical Spondylotic Radiculopathy. Journal of Guangzhou University of Traditional Chinese Medicine. 2023;41(2):373-378. doi:10.13359/j.cnki.gzxbtcm.2024.02.017. |
| 18711761 | Background | Lin JG, Chen WL. Acupuncture analgesia: a review of its mechanisms of actions. Am J Chin Med. 2008;36(4):635-45. doi: 10.1142/S0192415X08006107. |
| 21168100 | Background | Bono CM, Ghiselli G, Gilbert TJ, Kreiner DS, Reitman C, Summers JT, Baisden JL, Easa J, Fernand R, Lamer T, Matz PG, Mazanec DJ, Resnick DK, Shaffer WO, Sharma AK, Timmons RB, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J. 2011 Jan;11(1):64-72. doi: 10.1016/j.spinee.2010.10.023. |
| 16049211 | Background | Carette S, Fehlings MG. Clinical practice. Cervical radiculopathy. N Engl J Med. 2005 Jul 28;353(4):392-9. doi: 10.1056/NEJMcp043887. No abstract available. |
| ID | Term |
|---|---|
| D055009 | Spondylosis |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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